K Number

Device Name

ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS

Manufacturer

Boston Scientific Corporation

Date Cleared

2014-05-14

(162 days)

Product Code

FGE DEV

Regulation Number

876.5010

Intended Use

The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers are intended for delivery of the stent to the pancreatic duct (PD): · Used to drain pancreatic ducts

Device Description

The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers product consists of pancreatic stents and delivery systems or stent pushers. The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic marker, fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent. The Advanix Pancreatic Stent is designed for pancreatic duct (PD) drainage. The stent is constructed of a radiopaque (RO) polymer. The leading end has a tapered or rounded tip and the trailing end of the stent has an endoscopically visible marker to aid in placement. Stent sizes 4F and 5F contain a RO marker while 3F stents do not. The stent is available in two different shapes: straight stent and single pigtail. 3F and 4F stents have no-leading barb; 5F stents are available with and without a leading barb. Stent sizes 7F and 10F contain an RO marker except for the 3cm length stents. The 7F stent is available in two different shapes: straight stent and single pigtail. The 10F stent is only available in the straight stent shape. The pusher is constructed of RO polymer. The trailing end of the pusher has a white indicator to indicate the non-working end. There are 2 pusher options: RX and longwire. The RX pusher has a guidewire exit marker on the leading end to indicate the guidewire exit location. The wire for the longwire pusher exits at the trailing end of the pusher. The delivery system consists of a guide catheter connected to a pull-wire, and a push catheter connected to a locking mechanism. The locking mechanism is designed to keep the guide catheter in the position desired while being delivered to the deployment site. The stent can be deployed by disengaging the locking mechanism and retracting the guide catheter.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101314, K900923, K900923

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of the stent and delivery system, with no mention of AI or ML.

Therapeutic

Yes
The device, a pancreatic stent and delivery system, is intended to drain pancreatic ducts, which is a therapeutic intervention for a medical condition.

Diagnostic

Explanation: The device is a pancreatic stent and delivery system designed to drain pancreatic ducts, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly details physical components such as stents, delivery systems, and pushers, which are hardware. The performance studies also focus on the physical properties and biocompatibility of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "drain pancreatic ducts" by delivering a stent. This is a therapeutic intervention performed in vivo (within the body).
Device Description: The device is a physical stent and a delivery system used to place the stent within the pancreatic duct. This is a medical device used for treatment.
IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.

The device is clearly a medical device used for a therapeutic procedure, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers is intended for delivery of the stent to the pancreatic duct (PD): . · Used to drain pancreatic ducts

Product codes (comma separated list FDA assigned to the subject device)

FGE

Device Description

The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers product consists of pancreatic stents and delivery systems or stent pushers.

The pancreatic stents are provided in straight or single pigtail shape. The straight shape stents have trailing barbs and/or leading barbs depending on application, a rounded or tapered leading end tip to facilitate access through the papilla, and a rounded trailing end to abut the push catheter portion of the delivery system or stent pusher. The single pigtail stent may or may not have leading end barbs depending on application. Some stents have lateral drainage holes in the pigtails, a tapered or rounded leading end tip, and a rounded trailing end. All stents have either an endoscopic marker, fluoroscopic marker, or both on the trailing or leading end of the stent to assist with depth of placement in the pancreatic duct. The location and presence of an endoscopic or fluoroscopic marker is dependent on the length and diameter size of the stent. Some codes have side port holes in the body of the stent.

The Advanix Pancreatic Stent is designed for pancreatic duct (PD) drainage. The stent is constructed of a radiopaque (RO) polymer. The leading end has a tapered or rounded tip and the trailing end of the stent has an endoscopically visible marker to aid in placement. Stent sizes 4F and 5F contain a RO marker while 3F stents do not. The stent is available in two different shapes: straight stent and single pigtail. 3F and 4F stents have no-leading barb; 5F stents are available with and without a leading barb. Stent sizes 7F and 10F contain an RO marker except for the 3cm length stents. The 7F stent is available in two different shapes: straight stent and single pigtail. The 10F stent is only available in the straight stent shape.

The pusher is constructed of RO polymer. The trailing end of the pusher has a white indicator to indicate the non-working end. There are 2 pusher options: RX and longwire. The RX pusher has a guidewire exit marker on the leading end to indicate the guidewire exit location. The wire for the longwire pusher exits at the trailing end of the pusher.

The delivery system consists of a guide catheter connected to a pull-wire, and a push catheter connected to a locking mechanism. The locking mechanism is designed to keep the guide catheter in the position desired while being delivered to the deployment site. The stent can be deployed by disengaging the locking mechanism and retracting the guide catheter.

The delivery system, stent pushers and stent for this product have the following technological characteristics:

. Range of delivery systems and pushers tailored to the stents
Range of stents that are deliverable and removable through the endoscope .
Stents with a pigtail, and trailing and/or leading barbs .
Radiopaque stent, pusher and delivery system designed to be easily identifiable under . fluoroscopy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pancreatic duct (PD)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed Boston Scientific Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers were evaluated in accordance with EN ISO 10993-1:2009- Evaluation and Testing within a risk management system. The following tests were performed on the stent: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implant, USP Physicochemical, and Latex.

The delivery system and pushers were evaluated in accordance with EN ISO 10993-1:2009. The following tests were performed on the delivery system and pushers: Cytotoxicity, Sensitization, Irritation, USP Physicochemical and Latex.

The following tests were conducted on the Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers: Drainage Lumen ID, Stent Length, Stent Outer Diameter, Pigtail Stent Shape, Pigtail Stent Diameter, No-Leading Barb Stent Stiffness, Leading Barb Stent Stiffness, Stent Tensile, Pusher Working Length, Delivery System Working Length, Pusher OD, Delivery System Push Catheter OD, Pusher Deployment Force. Delivery System Deployment Force, Pusher Trackability Force, and Delivery System Trackability Force.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K101314, K900923, K900923

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Summary

MAY 1 4 2014

SECTION 5 510(k) SUMMARY

1. Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Elena Nieves Principal, Regulatory Affairs Specialist Telephone: 508-683-4430 Fax: 508-683-5939

Date Prepared: November 26, 2013

2. Device

Trade Name:

Classification Name: Product Code: Device Class and panel: Classification Regulation:

3. Predicate Devices

Trade Name: Trade Name: Manufacturer and Clearance Number: Classification Name: Product Code: Device Class and panel: Classification Regulation:

Trade Name:

Manufacturer and Clearance Number: Classification Name: Product Code: Device Class and panel: Classification Regulation:

Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers Biliary Catheters and Accessories FGE - Biliary Catheter and accessory Class II, Gastroenterology/Urology CFR 876.5010

Zimmon Endoscopic Pancreatic Stent Geenen Pancreatic Stent Wilson-Cook, K900923 Biliary Catheters and Accessories FGE - Biliary Catheter and accessory Class II, Gastroenterology/Urology CFR 876.5010

Advanix™ Biliary Stent with NaviFlex™ RX Delivery System Boston Scientific Corporation, K101314 Biliary Catheters and Accessories FGE - Biliary Catheter and accessory Class II, Gastroenterology/Urology CFR 876.5010

4. Device Description

The Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers product consists of pancreatic stents and delivery systems or stent pushers.

5. Indication for Use:

6. Technological Characteristics:

The delivery system, stent pushers and stent for this product have the following technological characteristics:

. Range of delivery systems and pushers tailored to the stents
Range of stents that are deliverable and removable through the endoscope .
Stents with a pigtail, and trailing and/or leading barbs .
Radiopaque stent, pusher and delivery system designed to be easily identifiable under . fluoroscopy.

When compared with the predicate devices [Boston Scientific Advanix Biliary Stent with NaviFlex RX Delivery System (K101314), Wilson-Cook Zimmon Pancreatic Stent (K900923), and Wilson-Cook Geenen Pancreatic Stent (K900923)] the proposed Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers has the same the technological characteristics as follows: identical indication statement; offered in the same stent lengths that range from 2cm -18cm; offered in the same stent shape configurations (straight and single pigtail; leading and no-leading barb); offered in the same stent outer diameter that range from 3F to 10F; offered in the same Pusher outer diameter (OD) that range from 3F to 5F; offered in the delivery system OD that range from 7F to 10F; and offered in the same delivery system working length of 202.5cm. The proposed devices technological characteristics that are similar in comparison to the predicate device are the stent and delivery system materials, and pusher working length.

7. Performance Data:

8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Boston Scientific AdvanixTM Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers is substantially equivalent to the currently marketed Boston Scientific Corporation Advanix('M Biliary Stent with NaviFlex™ RX Delivery System (K101314), Wilson-Cook Zimmon Endoscopic Pancreatic Stent (K900923) and Wilson-Cook Geenen Pancreatic Stent (K900923).

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2014

Boston Scientific Corporation Elena Nieves Principle, Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K133700

Trade/Device Name: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 17, 2014 Received: April 21, 2014

Dear Elena Nieves,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

Page 2 - Elena Nieves

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows the name "Benjamin Fisher-S". The name is written in a simple, sans-serif font. The letters are black and the background is white. The letters "FDA" are in the middle of the name.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

SECTION 4 INDICATIONS FOR USE STATEMENT

Indications for Use:

510(k) Number (if known): K133700

Device Name: Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers

Indications for Use:

Prescription Use X (Part 21 CFR 801 Part D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/11 description: The image contains the name "Benjamin R. Fisher -S" on the top line. The second line contains the date "2014.05" and the time "-04'00'". The text appears to be a signature or stamp.

Premarket Notification, Advanix Pancreatic Stent